(71 days)
The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.
The Bard Lubricious Ureteral Stent is a polyurethane stent with a hydrophilic (lubricious) coating which is intended to aid in stent insertion/removal and which has the potential to enhance patient comfort while indwelling; the stent also incorporates a monofilament suture loop which aids in stent removal.
This is a 510(k) premarket notification for a medical device (Bard® InLay™ Lubricious Double Pigtail Ureteral Stent) seeking substantial equivalence to a predicate device, not an AI/ML software device. Therefore, many of the requested criteria related to AI/ML device evaluations (e.g., ground truth, reader studies, effect size) are not applicable.
However, I can extract information related to the device's technical characteristics and how its performance was assessed in relation to the predicate device.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" are typically that the new device meets the same design, manufacturing, and performance specifications as the predicate device or relevant standards, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" demonstrates that these criteria are met.
| Acceptance Criterion (Implied/Standard for Ureteral Stents) | Reported Device Performance (Bard Lubricious Ureteral Stent) |
|---|---|
| Indications for Use (same as predicate) | Identical to predicate device: "The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique." |
| Disposable | Yes |
| Sterile | Yes |
| Stent Base Material (Polyurethane) | Polyurethane |
| X-Ray Opaque | Yes |
| Coating (Hydrophilic polymer / lubricious) | Hydrophilic polymer (lubricious)* (Different formula, different supplier than predicate) |
| Fr. Sizes Available (e.g., 4.7, 6, 7, 8 Fr.) | 4.7**, 6, 7 and 8 Fr. (4.7 Fr. stent will have a taper on the kidney-end tip) |
| Double Pigtail Lengths (e.g., 14-30cm) | 14, 20-30cm* (16 and 18cm lengths deleted compared to predicate) |
| Multilength Lengths (22-32cm) | 22-32cm (one overall adjustable length) |
| Pigtail Geometry | 360° curvature + 45° overlap (both ends) - (Predicate had "J" curl with no overlap. This is a difference, but not stated as failing an acceptance criterion, rather a design change.) |
| Suture Loop (USP Medical Grade nylon monofilament) | Yes - USP Medical Grade black nylon monofilament; 3-0 (Predicate had dark blue nylon. Color change, but both biocompatible.) |
| Guidewire Interface | 4.7 Fr. = .035" diameter*; 6, 7, 8 Fr. = .038" diameter* (4.7 Fr. interfaces with larger diameter guidewire than predicate) |
| Stent Clamp | Yes |
| Push Catheter Color | Orange* (Predicate was green. Color change.) |
| Push Catheter Material (HDPE) | High Density Polyethylene (HDPE) |
| Push Catheter Radiopacity | Radiopaque marker band near distal end* (Predicate N/A. Added feature.) |
| Push Catheter Length | 4.7, 6, 7, 8 Fr. = 17.75"* (Lengths changed; OD on new push catheter same as stent.) |
| Compliance with Standards | "Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document discusses performance and functional testing against standards and guidelines, rather than a clinical "test set" in the context of an AI/ML algorithm evaluation. No specific sample sizes for clinical data, country of origin, or retrospective/prospective nature are mentioned because the submission relies on bench testing and material specifications to demonstrate substantial equivalence to the predicate device, which is a common approach for device modifications under 510(k). Clinical data may not be required if the technological characteristics are shown to be substantially equivalent and do not raise new safety or effectiveness concerns.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" established by experts is a concept primarily relevant to the evaluation of diagnostic software, especially AI/ML, where human interpretation is being compared or enhanced. This submission is for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device substantial equivalence submission where bench testing against standards is performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is for a physical device, not an AI/ML diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical device like a ureteral stent, the "ground truth" for proving performance typically involves:
- Material specifications and biocompatibility testing: Ensuring the materials used are safe and perform as intended.
- Mechanical and functional testing: Bench testing the device to ensure properties like tensile strength, flexibility, flow rates, and in-vivo behavior (e.g., kink resistance, migratory prevention) meet established standards or are comparable to the predicate.
- Sterilization validation: Ensuring the device is sterile.
- Packaging integrity testing.
The submission states, "Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997." These standards and guidelines serve as the "ground truth" for evaluating the physical and functional aspects of the stent.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
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K9834498
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be filled with a solid black color. The font style is blocky and geometric, giving the word a strong and impactful appearance. The letters are evenly spaced and aligned horizontally.
SECTION VI
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
Submitter's Name: Address:
Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation:
C. R. Bard, Inc., Urological Division 8195 Industrial Blvd. Covington, Georgia 30014 Georgia C. Abernathy (770) 784-6454 (770) 784-6419 September 30, 1998
- B. Device Name:
| Trade Name: | Bard® InLay™ Lubricious Double Pigtail Ureteral Stent withSuture |
|---|---|
| Common / Usual Name: | Bard Lubricious Ureteral Stent |
| Classification Name: | Ureteral Stent |
-
C. Predicate Device Name:
Bard Lubricious-Coated Ureteral Stent with Suture Trade Name: -
D. Device Description:
The Bard Lubricious Ureteral Stent is a polyurethane stent with a hydrophilic (lubricious) coating which is intended to aid in stent insertion/removal and which has the potential to enhance patient comfort while indwelling; the stent also incorporates a monofilament suture loop which aids in stent removal. -
E. Intended Use:
The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.
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- F. Technological Characteristics Summary:
Table VI-1 provides a tabulated comparison summary of the technological characteristics of the Bard Lubricious Ureteral Stent versus the predicate device.
| Product Characteristic | Bard Lubricious Ureteral Stent(this 510(k)) | Bard Lubricious-Coated UreteralStent with Suture(Predicate device) (#K903345) | Difference |
|---|---|---|---|
| Stent | |||
| Indications or IntendedUse | The Bard Lubricious Ureteral Stent isindicated to relieve obstruction in avariety of benign, malignant and post-traumatic conditions in the ureter such aspresence of stones and/or stonefragments, or other ureteral obstructionssuch as those associated with ureteralstricture, carcinoma of abdominal organs,retroperitoneal fibrosis or ureteraltrauma, or in association withExtracorporeal Shock Wave Lithotripsy(ESWL). The stent may be placed usingendoscopic surgical techniques orpercutaneously using standardradiographic technique. | The Bard Lubricious-Coated UreteralStent with Suture is indicated to relieveobstruction in a variety of benign,malignant and post-traumatic conditionsin the ureter such as presence of stonesand/or stone fragments, or other ureteralobstructions such as those associatedwith ureteral stricture, carcinoma ofabdominal organs, retroperitonealfibrosis or ureteral trauma, or inassociation with Extracorporeal ShockWave Lithotripsy (ESWL). The stentmay be placed using endoscopic surgicaltechniques or percutaneously usingstandard radiographic technique. | None |
| Disposable | Yes | Yes | None |
| Sterile | Yes | Yes | None |
| Stent Base Material | Polyurethane | Polyurethane | None |
| X-Ray Opaque | Yes | Yes | None |
| CoatingDouble Pigtail | Hydrophilic polymer (lubricious)* | Hydrophilic polymer (lubricious) | Different formula,different supplier |
| Multilength | Hydrophilic polymer (lubricious) | None | Not previouslycoated |
| Fr. Sizes Available | 4.7**, 6, 7 and 8 Fr. | 4.7, 6, 7 and 8 Fr. | 4.7 Fr. stent willhave a taper on thekidney-end tip |
| Double Pigtail Lengths | 14, 20-30cm* | 14-30cm | 16 and 18cmlengths deleted |
| Multilength Lengths | 22-32cm (one overall adjustable length) | 22-32cm (one overall adjustable length) | None |
| Pigtail GeometryDouble Pigtail | 360° curvature + 45° overlap (both ends) | "J" curl configuration (no overlap) | Additional curllength |
| MultilengthSuture Loop | Yes-USP Medical Grade black nylonmonofilament; 3-0 | Yes-USP Medical Grade dark blue nylonmonofilament; 3-0 | Color change, bothbiocompatible |
| Guidewire Interface | 4.7 Fr. = .035" diameter*6, 7, 8 Fr. = .038" diameter* | 4.7 Fr. = .025" diameter6, 7, 8 Fr. = .038" diameter* | 4.7 Fr. interfaceswith larger diameterguidewire |
| Stent Clamp? | Yes | Yes | None |
| Table VI-1 |
|---|
| Comparison Summary of Technological Characteristics |
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| Product Characteristic | Bard Lubricious Ureteral Stent(this 510(k)) | Bard Lubricious-Coated UreteralStent with Suture(Predicate device) (#K903345) | Difference |
|---|---|---|---|
| Push Catheter | |||
| Color | Orange* | Green | Color change |
| Material | High Density Polyethylene (HDPE) | High Density Polyethylene (HDPE) | None |
| Guidewire Interface | 4.7 Fr. = .035" diameter*6, 7/8 Fr. = .038" diameter* | 4.7 Fr. = .025" diameter6/7/8 Fr. = .038" diameter | 4.7 Fr. interfaceswith larger diameterguidewire |
| Radiopacity | Radiopaque marker band near distal end* | N/A | Add radiopaqueband |
| Length | 4.7, 6, 7, 8 Fr. = 17.75"* | 4.7 Fr. = 22"6/7/8 Fr. = 16" | Length changed,OD on new pushcatheter same asstent |
New feature(s) or change this 510(k) *
- ** 4.7 Fr. stent will have a taper on the kidney-end tip
G. Performance Data Summary:
The Bard Lubricious Ureteral Stent referenced in this submission is held to the same design, manufacture, and performance specifications as those stents currently manufactured. Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and body. The symbol is rendered in a thick, black line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 1998
Georgia C. Abernathy Regulatory Affairs Associate C.R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209
Re: K983498
Bard® Inlay™ Lubricious Double Pigtail Ureteral Stent Dated: September 30, 1998 Received: October 5, 1998 Regulatory Class: II 21 CFR 876.4620/Procode: 78 FAD
Dear Ms. Georgia:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Eederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compirance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION I - D
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Bard Lubricious Ureteral Stent
Indications for Use:
The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription Use (Per 21 CFR 801.109)
،
Over The-Counter Use ____________________ OR
(Optional Format 1/2/96)
David L. Ingram
ivision Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).